Absolute Bioavailability and ADME study of Savolitinib (QSC204066)
Research type
Research Study
Full title
A Phase I Open-label, Study to Assess the Absolute Bioavailability of Savolitinib and Absorption, Distribution, Metabolism, Excretion of [14C]Savolitinib in Healthy Male Subjects
IRAS ID
287366
Contact name
Solange Corriol-Rohou
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2020-004354-29
Duration of Study in the UK
0 years, 1 months, 24 days
Research summary
Research Summary
The Sponsor is developing the test medicine, savolitinib, for the potential treatment of cancer. Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably, causing a growth called a tumour. The test medicine works to inhibit a pathway within the body which promotes tumours to grow and spread.The study involves radiolabelling (labelling the molecule with radioactive 14C) which is used to locate the molecule within the body. The study will try to evaluate the absolute bioavailability of the test medicine (amount of the oral test medicine that enters the blood stream relative to the dose given into the vein), along with the mass balance (how much radioactivity can be recovered from the urine and faeces) and the rates and routes of elimination of [14C]savolitinib. It will also look to identify the breakdown products (metabolites) of the test medicine. The safety and tolerability of the test medicine will be assessed.
The study will consist of two parts, involving up to eight healthy male volunteers. In Part one, following a high fat breakfast, volunteers will receive a single oral dose of the test medicine, followed by an intravenous infusion (solution into the vein) of radiolabelled test medicine. Volunteers will remain resident in the clinical unit until 72 hours post-oral dose.
There will then be a washout period of at least 14 days, after which the volunteers will return to the clinical unit for Part two. Volunteers will receive a single oral dose of radiolabelled test medicine as an oral solution. Blood, urine and faecal samples will be collected from volunteers whilst they are resident in the clinical unit for up to 168 hours post-dose (Day 8). Volunteers will return for a follow-up visit at least 14 days after their last dose for safety assessments.
Summary of Research
A lay summary of results is currently not available, this will be made available and posted on trialsummaries.com within two years of the study completion date.REC name
HSC REC A
REC reference
20/NI/0135
Date of REC Opinion
2 Nov 2020
REC opinion
Further Information Favourable Opinion